Zealand Pharma has announced that the global licensing agreement with sanofi-aventis has been amended to provide for the development and commercialization of Lixisenatide (AVE0010/ZP10) in combination with Lantus®, sanofi-aventis’ recombinant human insulin analog.
Lixisenatide is a Zealand-invented GLP-1 (glucagon-like-peptide-1) receptor agonist for the treatment of Type-2 Diabetes, and uses Zealand’s proprietary SIP™ (structure
inducing probe) peptide modification technology. Lantus® is sanofi-aventis’ number one brand with 2009 sales of more than €3 Billion. In April 2010, sanofi-aventis reported
positive Phase III results from the first of nine clinical studies within the Lixisenatide GetGoal Phase III program. Filing of Lixisenatide is expected to take place in H2 2011
in Europe & H2 2012 in the US.
The Phase III clinical program for the Lantus® + Lixisenatide combination product is expected to commence in 2010. Zealand knows of no similar Type-2 Diabetes product
that is as advanced in clinical testing.